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NCT01921335 · ClinicalTrials.gov registry record · Phase 1

ARRY-380 + Trastuzuamab for Breast w/ Brain Mets

A Phase 1 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT01921335 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 41 participants.

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The verdict

NCT01921335, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to test the safety of different doses of ARRY-380 in combination with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested. Both agents block the HER2 receptor, which is thought to be overactive in HER2-positive breast cancer. It is thought that ARRY-380 and trastuzumab might work together because they attach to different parts of the HER2 receptor and prevent it from functioning. Because HER2 positive breast cancer contains high levels of HER2 receptor, but normal cells in your body generally do not, the drugs may be able to "target" the cancer cells. In addition, in laboratory studies, ARRY-380 appears to have some penetration into the brain.

Interventions

  • DRUG Trastuzumab
  • DRUG ARRY-380 Twice Daily Dosage
  • DRUG ARRY-380 Once Daily

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2013-08
Est. Completion 2023-12-31
Phase Phase 1

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT01921335

The ClinicalTrials.gov registry entry for NCT01921335 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.

NCT01921335 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01921335 about?

NCT01921335 is a clinical study titled "ARRY-380 + Trastuzuamab for Breast w/ Brain Mets". The purpose of this study is to test the safety of different doses of ARRY-380 in combination with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested. Both agents block the ...

What is the current status of trial NCT01921335?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-08. Estimated completion is 2023-12-31.

What interventions are being tested in trial NCT01921335?

The interventions under investigation include: Trastuzumab (DRUG), ARRY-380 Twice Daily Dosage (DRUG), ARRY-380 Once Daily (DRUG).

Who is sponsoring clinical trial NCT01921335?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.